Evaluation of the Spiration Valve for Emphysema to Improve Lung Function
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 13-002690
NCT ID: NCT01812447
Sponsor Protocol Number: CPR-03434
About this study
This is a multicenter, prospective, randomized, controlled study designed to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group.
The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Subject has severe and heterogeneous emphysema with severe dyspnea
- Subject certified to meet the criteria of ATS/ERS guidelines for management of stable COPD
- Subject must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m
- Subject has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study
- Pulmonary Function Testing Results (PFT's) demonstrate
- FEV1 ≤ 45% of predicted
- RV ≥ 150% of predicted
- TLC ≥ 100% of predicted
Exclusion Criteria
- Patient has a BMI < 15 kg/m2 or > 35 kg/m2
- Arterial Blood Gas Level (ABG) indicates
- PCO2 > 50 mm Hg
- PO2 < 45 mm Hg on room air
- Subject has a diffuse emphysema pattern or α1-antitrypsin deficiency
- Subject has bronchitis with sputum production > 4 Tablespoons or 60 ml per day
- Subject has an active asthma (>15 mg of prednisone daily)
- Giant bulla (> 1/3 volume of lung)
- Pulmonary hypertension
- Subject with prior major lung surgery or recent hospitalization for COPD exacerbation or respiratory infection
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Jorge Mallea, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available